Effectiveness of Intensive Cognitive Behavioral Therapy in Treating Adolescent Panic Disorder and Agoraphobia

Intensive Treatment of Adolescent Panic and Agoraphobia

This study will evaluate the effectiveness of intensive cognitive behavioral therapy in treating adolescents with panic disorder with agoraphobia.

Study Overview

• Status: Completed
• Conditions: Panic Disorder; Agoraphobia
• Intervention / Treatment: Behavioral: Intensive panic control treatment without parent involvement; Behavioral: Intensive panic control treatment with parent involvement; Other: Waitlist control

Detailed Description

Panic disorder (PD) in adolescents is a prevalent and chronic anxiety disorder. People with PD experience unexpected attacks of fear, along with elevated heart rate, dizziness, faintness, weakness, and increased sweating. During these panic attacks, people may feel numbness in their hands, flushed or chilled, nauseous, or pain in the chest, and they may lose touch with reality. PD can lead to substantial social impairment for adolescents, including avoidance of school, independent activities, and peer involvement. When PD progresses so far that a person avoids public places where a panic attack might occur, the person is said to have a condition known as agoraphobia. Weekly sessions of cognitive behavioral therapy (CBT) appear to be effective in treating panic disorder with agoraphobia (PDA). However, many adolescents with PDA and their families report the need for a more immediate relief from the disorder. This study will evaluate the effectiveness of intensive CBT in treating adolescents with PDA.

Participants in this single blind study will be randomly assigned to one of three conditions: intensive CBT treatment including family members, intensive CBT treatment without family members, or a waitlist control group. All participants in the intensive CBT treatment groups will undergo 8 days of intensive CBT, for a total of 6 sessions. On Days 1 through 3 of treatment, participants will attend daily, 2-hour CBT sessions. The CBT sessions will include psychoeducation about anxiety, tactics to restructure anxiety-provoking thoughts, and exposure to bodily sensations that trigger panic. On Days 4 and 5, participants will meet with a therapist to learn ways to approach previously feared situations. On Days 6 and 7, participants will continue working independently or with family members to solidify skills. On Day 8, participants will attend a final 2-hour session to consolidate skills, review the independent weekend activities, and discuss ways to apply skills to the home environment. Parents of participants in the parental involvement group will attend the last 30 minutes of sessions, complete homework assignments, learn ways to coach their children through episodes, and participate in selected exposures. After 6 weeks of waitlist, participants in the waitlist control group will receive active treatment following the same procedures as the initial active treatment. All participants will be assessed at Months 3, 6, and 12 post-treatment.

• Study Type: Interventional
• Enrollment (Actual): 63
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Boston University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Meets DSM-IV criteria for principal diagnosis of PD or PDA prior to treatment
• Adolescent must be accompanied by at least one parent or caregiver
• If on medication, there must be a 1-month stabilization period for benzodiazepines or 3-month stabilization period for SSRIs or tricyclics prior to study entry

Exclusion Criteria:

• Positive diagnosis of schizophrenia, pervasive developmental disorder, organic brain syndrome, mental retardation, or current suicidal ideation
• Unavailability of at least one parent or caregiver
• Refusal of parent to accept random assignment to treatment condition
• Refusal of parent or adolescent to accept stabilization of medication
• Adolescent with parent who has any condition that would limit ability to understand treatment

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; Participants will receive intensive cognitive behavioral therapy treatment without parent involvement	Behavioral: Intensive panic control treatment without parent involvement; Intensive panic control treatment without parent involvement is an 8-day, intensive form of cognitive behavioral therapy (CBT) with exposure, including 15-20 hours of direct therapist contact. The basic treatment components are psychoeducation about anxiety, restructuring anxiety-provoking thoughts, exposure to bodily sensations that trigger panic, and in vivo exposures.
Experimental: 2; Participants will receive intensive cognitive behavioral therapy treatment with parent involvement	Behavioral: Intensive panic control treatment with parent involvement; Intensive panic control treatment with parent involvement involves the same form of intensive CBT, but with direct parent involvement. Parents will attend the last 30 minutes of didactic sessions, complete homework assignments, learn ways to coach their children, and participate in selected exposures.
Placebo Comparator: 3; Waitlist control group	Other: Waitlist control; Waitlist control participants will receive active treatment (treatment with or without family involvement) after 6 weeks of waitlist.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Anxiety Disorders Interview Schedule-Child and Parent Versions: Clinical Severity Rating, Agoraphobia Ratings, Panic Attack Frequency Scores, and Internal Sensation Anxiety Ratings	Measured at Months 3, 6, and 12 post-treatment
Panic Disorder Severity Scale-Child Version	Measured at Months 3, 6, and 12 post-treatment

Secondary Outcome Measures

Outcome Measure	Time Frame
Multidimensional Anxiety Scale for Children	Measured at Months 3, 6, and 12 post-treatment
Childhood Anxiety Sensitivity Index	Measured at Months 3, 6, and 12 post-treatment
Fear and Avoidance Hierarchy	Measured at Months 3, 6, and 12 post-treatment
Children's Depression Inventory	Measured at Months 3, 6, and 12 post-treatment
The Panic Attack Record	Measured at Months 3, 6, and 12 post-treatment
Subjective Symptoms Scale	Measured at Months 3, 6, and 12 post-treatment
Panic and Phobia Questionnaire	Measured at Months 3, 6, and 12 post-treatment
Participant Global Impression of Improvement (PGI)	Measured at Months 3, 6, and 12 post-treatment
Perceptions of Treatment Questionnaire: Adolescent and Parent Versions	Measured at Months 3, 6, and 12 post-treatment
Children's Perception Scale (Locus of Control Scale)	Measured at Months 3, 6, and 12 post-treatment
Child Behavior Checklist (CBCL)	Measured at Months 3, 6, and 12 post-treatment
Stress Index for Parents of Adolescents	Measured at Months 3, 6, and 12 post-treatment
Parenting Locus of Control Scale	Measured at Months 3, 6, and 12 post-treatment
Therapy Attitude Inventory	Measured at Months 3, 6, and 12 post-treatment
Family Assessment Measure (FAM)	Measured at Months 3, 6, and 12 post-treatment
Depression Anxiety and Stress Scale (DASS)	Measured at Months 3, 6, and 12 post-treatment

Collaborators and Investigators

• Sponsor: Boston University
• Collaborators: National Institute of Mental Health (NIMH)
• Investigators: Principal Investigator: Donna Pincus, PhD, Boston University

Study record dates

Study Major Dates

• Study Start: March 1, 2005
• Primary Completion (Actual): March 1, 2011
• Study Completion (Actual): March 1, 2011

Study Registration Dates

• First Submitted: December 17, 2007
• First Submitted That Met QC Criteria: December 17, 2007
• First Posted (Estimate): December 19, 2007

Study Record Updates

• Last Update Posted (Estimate): February 20, 2014
• Last Update Submitted That Met QC Criteria: February 19, 2014
• Last Verified: February 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders; Panic Disorder; Agoraphobia
• Other Study ID Numbers: R01MH068277 (U.S. NIH Grant/Contract); DSIR 84-CTS (Division of Services and Intervention Research)